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510(k) K191194

Device
CLARUS
Applicant
Carl Zeiss Meditec, Inc
510(k) number
K191194
Product code
QER  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-25
Date received
2019-05-03
Regulation
886.1120
Classification name
Camera, Ophthalmic, Slit-scanning
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Saurabh Jamkhindikar
Address
5160 Hacienda Dr. Dublin CA US 94568 94568

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QER  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243878CLARUS (700)Carl Zeiss Meditec, Inc.2025-04-17
K181444CLARUSCarl Zeiss Meditec, Inc.2019-01-10

Legacy Summary#

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FDA Review#

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